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Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions.

Authors
  • Rijsbergen, Melanie1
  • Rijneveld, Rianne1
  • Todd, Marina1
  • Feiss, Gary L2
  • Kouwenhoven, Stijn T P3
  • Quint, Koen D3
  • van Alewijk, Dirk C J G4
  • de Koning, Maurits N C4
  • Klaassen, Erica S1
  • Burggraaf, Jacobus1, 5
  • Rissmann, Robert1, 5
  • van Poelgeest, Mariëtte I E1, 6
  • 1 Centre for Human Drug Research, Leiden, the Netherlands. , (Netherlands)
  • 2 Cutanea Life Sciences, Wayne, Pennsylvania, USA.
  • 3 Department of Dermatology,, Leiden University Medical Centre, Leiden, the Netherlands. , (Netherlands)
  • 4 DDL Diagnostic Laboratory, Rijswijk, the Netherlands. , (Netherlands)
  • 5 Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands. , (Netherlands)
  • 6 Department of Gynecology, Leiden University Medical Centre, Leiden, the Netherlands. , (Netherlands)
Type
Published Article
Journal
British Journal of Clinical Pharmacology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Nov 22, 2019
Identifiers
DOI: 10.1111/bcp.14181
PMID: 31755993
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

To assess safety and tolerability and explore pharmacodynamics and efficacy of omiganan in external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL). Two randomized controlled trials in patients with external AGW and vulvar HSIL were conducted. Patients received topical omiganan 2.5% or placebo gel once daily for 12 weeks with a follow-up of 12 weeks. Safety and tolerability were monitored and pharmacodynamics and clinical efficacy of omiganan were assessed by analysing lesion count, size and viral load. Self-reported pain, itch and quality of life were assessed by an electronic diary and questionnaire. Twenty-four AGW and 12 vulvar HSIL patients were enrolled. All patients had a high treatment adherence (99%). No serious adverse events occurred and all adverse events (n = 27) were mild, transient and self-limiting. The treatment groups were not different in terms of safety and tolerability, lesion count and size, and patient-reported outcomes pain, itch and quality of life. Human papillomavirus load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% confidence interval -99.9 to -7.4%; P = .045) in AGW patients only. Topical omiganan appears to be safe in patients with AGW and vulvar HSIL and reduced human papillomavirus load after 12 weeks of treatment in AGW patients. © 2019 The British Pharmacological Society.

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